Comparison of satisfaction in dental treatments using patient-controlled sedation methods with midazolam, remimazolam, and dexmedetomidine
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008615
- Lead Sponsor
- Seoul National University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
? Patients aged 20 years or older and under 60 years old.
? Patients who meet the American Society of Anesthesiologists Physical Status (ASA PS) criteria of I or II.
? Patients with a body mass index (BMI) ranging from 18.5 to 30.
? Patients who have planned dental treatment under local anesthesia in oral and maxillofacial surgery and have given consent.
? Cases where dental treatment is expected to take place within 2 hours.
? Patients who have been informed about and consented to participate in a clinical trial on Patient-controlled sedation in dental anesthesia.
? Patients with hypersensitivity or allergies to sedatives or local anesthetics.
? Patients who are currently taking medications, such as analgesics, sedatives, psychiatric drugs, or any other medication that could potentially influence the results of the clinical trial.
? Patients classified as Mallampati III or IV.
? Patients who are pregnant or breastfeeding.
? Patients with liver, kidney, or brain function disorders.
? Patients with sleep apnea.
? Patients with Myasthenia gravis.
? Patients who are unable to read or understand the informed consent form.
? Other patients for whom the exclusion by the investigator is deemed necessary.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of sedation (OAA/S - Observer's Assessment of Alertness/Sedation), Vital signs (blood pressure, heart rate, oxygen saturation), Pain level (NRS - Numeric Rating Scale);Bispectral Index (BIS), Number of times the button on the patient-controlled sedation device was pressed/Total amount of medication administered, Additional sedative dosage/administration frequency, Dosage of local anesthetic used;Anesthesiologist's/dentist's/patient's subjective satisfaction with patient-controlled sedation, Intraoperative memory assessment
- Secondary Outcome Measures
Name Time Method Demographic information, Height, Weight, Mallampati classification, Medical history, Dental anxiety scale, Sleep duration;Occurrence of adverse reactions